Fennec Pharmaceuticals Inc. Q3 FY2024 Earnings Call

Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceuticals Third Quarter 2024 Earnings and Corporate Update Conference Call. At this time, all participants are in listen-only mode. Later we will conduct a question-and-answer session, and instructions on how to participate will begin at that time. As a reminder, today's conference call is being recorded. Now I would like to turn the conference over to Fennec's Chief Financial Officer, Robert Andrade.

Thank you, operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceuticals third quarter 2024 earnings conference call, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning is our Chief Executive Officer and Board member, Jeff Hackman. As a reminder, Jeff joined Fennec on August 5th and in just a few short months has made significant progress in positioning the company for near-term and future growth and sustainability. Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. Reference to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U.S. Securities and Exchange Commission. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on Fennec's website, www.fennecpharma.com, where it will be available for the next 30 days. Now with that behind us, I will now turn the call over to Jeff Hackman. Jeff?

Thank you, Robert, and good morning, everyone. This morning, I'm going to discuss the recent progress that we've been making, along with some key developments, including developments around market expansion, our academic endorsements, new demographic interest, our educational investments, our operational efficiencies, the strengthening of our leadership, and most importantly our execution, all of which will drive meaningful growth in the quarters ahead. So since joining Fennec in August, as Robert mentioned, I've conducted several planning sessions with our senior leadership teams across multiple functional areas. I've done a detailed deep dive in each territory of the business. I know where we are getting our business, and I know where we are not. We're making adjustments, including selective modifications to some of the historical spending that we've been doing. We also are going to align our goals and our actions with the company's long-term vision to ensure that all eligible platinum-treated cancer patients are spared from their hardships by protecting their ears against the profound threat of hearing loss. I've put into place some strategic imperatives and objectives with my team to drive execution and growth in the coming months and the years to come. These are five pillars that are going to drive our brand vision for PEDMARK, which, again, as a reminder, is the first and only therapy approved in the U.S. and Europe to reduce the risk of ototoxicity and permanent hearing loss associated with cisplatin treatments. Our first imperative is increasing the awareness around the unmet patient need and continuing to drive oncologists to recognize the importance of preventing hearing loss. Our second initiative is cementing PEDMARK as the standard of care for all prevention of hearing loss. Third is PEDMARK's adoption by healthcare providers beyond just the oncologists, but also gaining confidence and continued positive experiences throughout their offices with PEDMARK. Fourth is ensuring advocacy, payers, and providers guarantee seamless access for our product. And fifth, and equally important, is activation, especially around patients and caregivers, activating them through disease education and demand for PEDMARK. One of the most exciting developments that we're seeing in addition to pediatrics this quarter is the proof of concept emerging in the Adolescent and Young Adult market segment. The opportunity in the AYA segment is significant, with at least 10,000 patients treated annually with cisplatin, including primary tumors such as germ cell tumors and thyroid tumors. Over the months, I've personally met with some of these opinion leaders in AYA. I know many of them for years, and I've listened to them and have a better understanding of how we can help them and their patients avoid hearing loss. The physicians that have used PEDMARK are reporting compelling outcomes. The market potential for AYA is much greater than the size of the pediatric market, and it has a favorable reimbursement profile via the outpatient reimbursement market. In fact, in the third quarter, we surpassed greater than 90% reimbursement for PEDMARK in the AYA patient population. We have been very encouraged by the response from the AYA treating physicians to PEDMARK. Many of them, while being acutely aware of the hearing loss caused by cisplatin, were not aware of the availability of PEDMARK as a preventative treatment. As you know, PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized non-metastatic solid tumors. As you know, PEDMARK is recommended for the AYA population by the NCCN or the National Comprehensive Cancer Network. After several quarters of expanded awareness and activities focused on this community, the third quarter achieved multiple patients now being administered PEDMARK with successful reimbursements from major health plans. Further, we partnered with Orsini, a specialty pharmacy company, to administer multiple AYA patients within the Orsini partnership and platform at their homes. This partnership enables home administration and white bag delivery to the hospital with direct billing to the insurance provider or to Medicaid. This is all great news, and it's the beginning of what we believe is a strong sustainable revenue stream. We expect this segment to ramp up over the coming quarters. As an example of the opportunity in AYA, we have seen PEDMARK vials per patient increasing as high as 40 vials per patient, and the centers are repeating their orders for PEDMARK. We are also seeing adoption of PEDMARK in select new major academic centers versus substitutions or compounded versions of sodium thiosulfate, which pose potential serious health risks to patients. Academic institutions are critical in setting clinical standards. This transition and endorsement by these select institutions is powerful and signals broader market acceptance. This also opens up opportunities in research settings, positioning us well for potential future expansion. We're working on strategic initiatives to raise awareness of the risk of ototoxicity or permanent hearing loss associated with cisplatin treatment. To drive adoption of PEDMARK to ultimately help address the significant unmet need for cancer patients, these efforts include key opinion leader engagements, educational initiatives, and digital outreach, all of which are creating broader ecosystems for PEDMARK. We expect these initiatives to continue generating value over the long-term and in the quarters to come. In terms of the commercial launch and progress that we're making with PEDMARK outside the U.S., following the exclusive licensing agreement announcement we executed in March with Norgine to commercialize PEDMARQSI, the product is expected to launch in Germany and the U.K. in the coming months. This will generate an additional revenue source for Fennec in 2025. We look forward to providing future updates as the launch progresses in these countries. Regarding the investigator-initiated trial in Japan evaluating PEDMARK, it was fully enrolled as of October 2024. This clinical trial, called STS-J01, evaluates the efficacy and safety of PEDMARK in reducing ototoxicity induced by cisplatin in children and young adults with localized solid tumors. The primary endpoint of this trial is to assess the frequency of hearing impairment at the end of the treatment. Results of the trial are expected sometime in 2025, with the potential evaluation of both the registration and/or partnering or licensing of PEDMARK in Japan thereafter. Finally, we've significantly strengthened our executive leadership team with appointments of a few individuals, and I'd like to talk about them now. First is Pierre Sayad, who is now our Chief Medical Officer. There's Terry Evans, who is now our Chief Commercial Officer, and Christiana Cioffi, our Chief Strategy Officer. These roles are critically important for Fennec. Pierre will lead medical affairs, medical information, our key opinion leader engagement, and regulatory matters. Terry will lead our sales management, sales training, operations, trade, group purchasing organization, and field reimbursement. Christy will lead strategy, marketing, business operations, corporate development, business development, and alliance management. These are very experienced and multi-talented leaders, and we expect them to have a significant impact on Fennec as we embark on a new chapter in our organization's evolution. We're delighted to have Pierre, Terry, and Christy on board. All of them are seasoned biopharmaceutical industry executives, as I mentioned, with proven clinical, commercial sales, operation, and oncology market experience. Their leadership, combined with Fennec's talented employee base, will significantly accelerate our ability to build upon and seamlessly execute our commercial strategy for PEDMARK. As members of the executive leadership team, Pierre, Terry, and Christy will join Robert to partner with me to ensure cross-functional alignment, operational efficiencies, and executional excellence, all while creating high-performing teams and strengthening our culture within this organization. Thank you so much. And now I'm going to turn it back over to Robert to go through some of the financials of the quarter. Robert?

Thank you, Jeff. Our press release contains details of our financial results for the third quarter of 2024, which can be viewed in the Investors and Media section of our website. As customary, rather than read through all of those details, my comments today will focus on some key financial results. For the first nine months of 2024, the company has recorded approximately $22 million in net product sales, which is more than all of 2023 net product sales. Specifically for the quarter, the company recorded net product sales of $7.0 million compared to $6.5 million in the comparable quarter in 2023. General and administrative expenses for the third quarter of 2024 were $6.1 million, which compares to $3.8 million in the comparable quarter of 2023 and $6.9 million in the second quarter of 2024. The year-over-year increase in G&A can be attributed to noncash stock compensation related to both the separation of our CEO and our new CEO, as well as cash severance related to our previous CEO and ongoing IP litigation expenses. Selling and marketing expenses include remuneration for our sales and marketing employees, dollars spent on marketing campaigns such as sponsorships, trade shows, presentations, and activities to support marketing and sales efforts. The company recorded $4.6 million in selling and marketing expenses in the third quarter of 2024, compared to $4.7 million in the second quarter of 2024 and $3.4 million in the comparable quarter in 2023. Selling and marketing expenses continue to focus on awareness and education, with increased marketing expenses related to AYA initiatives year-over-year. Finally, regarding our cash position; we ended the third quarter with approximately $40.3 million in cash, cash equivalents, and investment securities. Excluding an approximately $0.7 million severance payment to our previous CEO, cash would have been nearly $41 million, representing a decrease of approximately $2 million for the quarter. The strength and sustainability of our operating model is evident this quarter as this was the smallest operating cash decrease for the company since launch, and speaks to the operational efficiency and potential cash contribution from a growing and sustainable revenue base. We anticipate that our cash and cash equivalents and investment securities as of September 30, 2024, will be sufficient to fund our planned operations into at least 2026. Before we open the call for questions, I'm going to turn it back to Jeff for closing remarks. Jeff?

Thank you, Robert. In closing, we are embarking on a whole new chapter in Fennec's evolution. As I've immersed myself in the business over the last 90 days, I'm even more excited to lead Fennec in this new role and direct this organization towards continued growth efforts in the future. We have an incredible opportunity with PEDMARK, and I'm excited about the potential we have here to drive the product and our company forward. We believe the developments I've outlined—market expansion, academic endorsements, new demographic interest, educational investments, operating efficiencies, strong leadership, and execution—will all drive meaningful growth in the quarters ahead. We're excited about the future, and we're looking forward to working together. I would like to thank you all today for joining our call and for your continued support of Fennec. We look forward to updating all of you on our ongoing commercial progress and corporate milestones in future quarterly calls. And with that, operator, I will now open it up to questions.

And your first question comes from Chase Knickerbocker with Craig-Hallum. Your line is open.

Good morning. Thanks for taking the questions. I guess just first to start on the AYA side of things. Jeff, do you feel like you have everything in place from a standpoint of really being able to accelerate and drive growth in that market? Maybe give us an update on the compendium. And then again, do you think it's kind of open season for you guys there? Does anything else need to fall into place? And should we start to expect some pretty meaningful growth from that market kind of sequentially here per your commentary on the call today? Thanks.

Thank you, Chase. Yes, we do believe the commercial opportunity is significant for PEDMARK and AYA. We're in the process now and especially as we brought new talent here around not only the marketing but also the medical side, their impact and the value they bring will be incremental to moving this opportunity forward. So to answer your question and looking forward, yes, we believe that this is a significant opportunity for us, without a doubt. The progress that we've made already in this quarter gives us the signal that we have the potential here, and we've got a significant growth opportunity.

Certainly. And I guess if we think about the potential kind of revenue per patient there with the weight-based dosing, it seemingly doesn't take many patients or much initial success to really start driving the model, Jeff. And so I guess just from that perspective, do you feel like you have enough doctors who you've gotten in front of where we can start to expect in Q4 that those patients start to flow through? And then just kind of overarching in that question, I think there are some difficulties in modeling your business in the near term. Anything you can help us with, Robert, as far as how to think about Q4, particularly with these AYA comments today? Thank you very much.

Thanks. I'll comment first, Robert, and then I'll hand it over to you. In Q3, we were able not only to begin having patients in the AYA segment treated with PEDMARK, but we also saw significant reimbursement, which was critically important. The insights from this market indicate that the incidence is present, the population is open, and the physicians want to hear the information. There is an awareness gap in the AYA market, but that's an opportunity for us, especially in this segment. We know there are potentially upwards of 10,000 patients treated annually with cisplatin across multiple tumor types. We know that ototoxicity exists in this population, and we're confident this significant opportunity will benefit the organization in the coming quarters. Robert, want to comment on the fourth quarter?

Yes. Thank you, Chase, and thanks for the question. As you heard in the script and our commentary, for Q3, we were quite pleased with the momentum we're building specifically with new customers, both in the AYA and in the pediatric segment. During the quarter, we had several new customers, including large pediatric institutions that had never ordered PEDMARK before, alongside the market proof within the AYA segment. As we secure these new customers and receive repeat orders from them and hopefully additional customers, we believe this will be the foundation of growth in the quarters to come.

Your next question comes from Raghuram Selvaraju with H.C. Wainwright.

Hi, thanks very much for taking my questions. Just three quick ones here. Jeff, I was wondering if you could comment on any changes in the behavior of those purchasing departments that historically have relied on compounded versions of sodium thiosulfate and if you are seeing any kind of shift in their disposition towards PEDMARK, and what you expect will potentially accelerate that trend going forward into the future? Secondly, I don't know if you're in a position at this juncture to comment generally and qualitatively on what Fennec anticipates to be the key business development objectives and priorities going forward from a strategic standpoint. Finally, I don't know whether either you or Robert want to talk about the status of ongoing IP litigation at this time and when you expect a resolution on that front? Thank you.

Sure. Yes. Thank you for your questions. I appreciate it. I'll take the first two, and maybe Robert can address the third. You were asking about what we're seeing on the pediatric side. As Robert mentioned, we are seeing multiple institutions this past quarter starting to move towards PEDMARK, where previously they were compounding. There are multiple reasons for this shift. In some cases, a side effect caused by compounding led certain institutions to move towards PEDMARK. My experience with these institutions spans many years. As we've said, the timing to engage with everyone necessary within these institutions, including consistent conversations and targeting Pharmacy & Therapeutics committees, requires persistence. In some cases, our early work at Fennec is now beginning to yield results. As for your second question, repeat it again?

I was wondering if you could provide us with some qualitative color regarding what you see as the business development priorities and principal initiatives for Fennec going forward at this point?

Certainly. There are some open territories that we're evaluating. As we mentioned regarding Japan, we will evaluate next steps in the first half of next year. There are many potential initiatives we could consider in a market the size of Japan. Now that the trial's enrollment is complete, we will soon start receiving updates on the trial's results in early 2025. So stay tuned for future developments regarding potential business opportunities. Robert, do you want to address the final question on IP?

Yes, thank you, Jeff. I'll add that we are very excited about the Norgine deal we announced back in March. As we’ve made progress and observed the Norgine's launch, we believe the value attributable to Fennec moving forward is often underappreciated by the market. With respect to the IP, it is prudent for me to avoid public comments. However, the case is ongoing. As seen in our filings, our IP portfolio has strengthened significantly over the last two years with six Orange Book patents added. So stay tuned for further updates, and thank you for your question.

Thank you.

I will now turn the call back to Jeff Hackman for closing remarks.

Thank you so much. I want to thank all of you for joining the call today and express gratitude to many of you for your ongoing support of Fennec. We look forward to updating you more either on one-on-one calls or ongoing commercial calls that we'll have over the quarter. Additionally, we look forward to future milestones achieved and our future quarterly calls wherein we can provide more updates. Thank you very much. Operator, I am going to hand it back to you to close the call.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.